Efficacy and Safety of Vibegron Add-On Therapy for Persistent Overactive Bladder Symptoms in Benign Prostatic Hyperplasia Patients With α1-Blocker Treatment: A Multi-Center Prospective Randomized Controlled Study (VATON Study)

IF 1.5 4区医学 Q3 UROLOGY & NEPHROLOGY

LUTS: Lower Urinary Tract Symptoms Pub Date : 2026-03-13 DOI:10.1111/luts.70053

Masaki Yoshida, Yoshinori Nishino, Hiroshi Nagae, Shinobu Kato, Sadaaki Sakamoto, Morifumi Hojo, Toshihide Miyauchi, Shinji Kageyama, Shinichi Takahashi, Hideya Kuroda, Naoki Mori, Yasuhiro Kasagi, Koichi Masunaga, Yoshiyuki Nabeshima, Masanori Nomiya, Koichi Iwashita, Koichi Miyamae, Masayuki Otani, Kazuya Kawahara, Makoto Ikeda, Shinichi Kubono, Nobuhiro Haga

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Abstract

Objectives

To evaluate the efficacy and safety of vibegron add-on therapy for persistent overactive bladder (OAB) symptoms after α₁-blocker monotherapy for benign prostatic hyperplasia (BPH).

Methods

Eligible patients were aged ≥ 50 years and diagnosed with BPH. All patients had received an α₁-blocker for ≥ 8 weeks, yet had persistent OAB symptoms. Patients were randomized 1:1 to receive add-on vibegron (50 mg) or to continue α₁-blocker monotherapy. The primary efficacy endpoint was the between-group difference from baseline (week 0) to week 12 in total overactive bladder symptom score (OABSS). Secondary endpoints included bladder diary parameters, OABSS subscores; International Prostate Symptom Score total, storage/voiding, quality-of-life score; and patient satisfaction assessed by the Patient Global Impression. Safety was assessed by recording treatment-emergent adverse events.

Results

Overall, 158 patients were randomized into two groups (n = 79 each). The least-squares mean change in the primary endpoint (OABSS total score) was −1.9 (95% confidence interval [CI]: −2.4 to −1.5) with α₁-blocker monotherapy and −3.3 (95% CI: −3.8 to −2.9) with vibegron add-on therapy; the between-group difference was −1.4 (95% CI: −2.0 to −0.8; p < 0.001), indicating a significant improvement with add-on therapy. Across the secondary endpoints, favorable outcomes were observed. Higher satisfaction was reported in the vibegron add-on therapy group than in the α₁-blocker monotherapy group. Vibegron was well tolerated, and no serious drug-related treatment-emergent adverse events were observed.

Conclusions

Vibegron add-on therapy to an α₁-blocker may be effective and safe for treating BPH with persistent OAB symptoms.

Abstract Image

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一项多中心前瞻性随机对照研究（VATON研究）：Vibegron加药治疗α - 1阻滞剂治疗的良性前列腺增生患者持续性膀胱过动症的疗效和安全性

目的：评价vibegron加药治疗α - 1阻滞剂单药治疗良性前列腺增生（BPH）后持续性膀胱过动症（OAB）的疗效和安全性。方法：患者年龄≥50岁，诊断为BPH。所有患者均接受α1受体阻滞剂治疗≥8周，但仍有持续的OAB症状。患者按1:1随机分组，接受附加vibegron （50mg）或继续α1受体阻滞剂单药治疗。主要疗效终点是从基线（第0周）到第12周膀胱过度活动症状总评分（OABSS）的组间差异。次要终点包括膀胱日记参数、OABSS评分；国际前列腺症状评分总分、储存/排尿、生活质量评分；患者满意度由患者全球印象评估。通过记录治疗中出现的不良事件来评估安全性。结果：158例患者随机分为两组（每组79例）。α1受体阻滞剂单药治疗的主要终点（OABSS总分）的最小二乘平均变化为-1.9(95%可信区间[CI]: -2.4至-1.5)，vibegron附加治疗的最小二乘平均变化为-3.3 (95% CI: -3.8至-2.9)；组间差异为-1.4 （95% CI: -2.0 ~ -0.8； p受体阻滞剂单药组）。Vibegron耐受性良好，未观察到严重的药物相关治疗不良事件。结论：Vibegron加用α1受体阻滞剂治疗BPH伴持续性OAB症状可能是安全有效的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

LUTS: Lower Urinary Tract Symptoms UROLOGY & NEPHROLOGY-

CiteScore

3.00

自引率

7.70%

发文量

审稿时长

>12 weeks

期刊介绍： LUTS is designed for the timely communication of peer-reviewed studies which provides new clinical and basic science information to physicians and researchers in the field of neurourology, urodynamics and urogynecology. Contributions are reviewed and selected by a group of distinguished referees from around the world, some of whom constitute the journal''s Editorial Board. The journal covers both basic and clinical research on lower urinary tract dysfunctions (LUTD), such as overactive bladder (OAB), detrusor underactivity, benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), urinary incontinence, pelvic organ prolapse (POP), painful bladder syndrome (PBS), as well as on other relevant conditions. Case reports are published only if new findings are provided. LUTS is an official journal of the Japanese Continence Society, the Korean Continence Society, and the Taiwanese Continence Society. Submission of papers from all countries are welcome. LUTS has been accepted into Science Citation Index Expanded (SCIE) with a 2011 Impact Factor.